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The American Journal of Managed Care August 2019
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Late Diagnosis of Hepatitis C Virus Infection, 2014-2016: Continuing Missed Intervention Opportunities
Anne C. Moorman, MPH; Jian Xing, PhD; Loralee B. Rupp, MSE; Stuart C. Gordon, MD; Mei Lu, PhD; Philip R. Spradling, MD; Joseph A. Boscarino, PhD; Mark A. Schmidt, PhD; Yihe G. Daida, PhD; and Eyasu H. Teshale, MD; for the CHeCS Investigators
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Late Diagnosis of Hepatitis C Virus Infection, 2014-2016: Continuing Missed Intervention Opportunities

Anne C. Moorman, MPH; Jian Xing, PhD; Loralee B. Rupp, MSE; Stuart C. Gordon, MD; Mei Lu, PhD; Philip R. Spradling, MD; Joseph A. Boscarino, PhD; Mark A. Schmidt, PhD; Yihe G. Daida, PhD; and Eyasu H. Teshale, MD; for the CHeCS Investigators
Late hepatitis C virus infection diagnosis points to a need for earlier screening and treatment before the onset of severe liver disease leading to high cost and diminished outcomes.
ABSTRACT

Objectives: Chronic hepatitis C virus (HCV) infection is typically asymptomatic until severe liver disease occurs and even then can remain undiagnosed for some time; thus, screening and treatment of asymptomatic persons are needed to prevent poor outcomes. In a previous analysis of data from between 2006 and 2011, we found that 17% of newly diagnosed HCV infections in 4 large health systems were among persons with cirrhosis and/or end-stage liver disease, termed “late diagnosis.” We sought to determine the proportion with late diagnosis during 2014-2016, after release of CDC baby boomer (1945-1965 birth cohort) testing guidelines in 2012.

Study Design: The cohort was based on analysis of electronic health records and administrative data of about 2.7 million patients visiting the same healthcare systems during 2014-2016.

Methods: Among persons with newly diagnosed chronic HCV infection during 2014-2016, we analyzed data collected up to January 1, 2017.

Results: Among 2695 patients with newly diagnosed HCV infection, 576 (21.4%) had late diagnosis. Most were born between 1945 and 1965 (n = 1613 [59.9%]), and among these, 27.6% had late diagnosis. Patients with versus without late diagnosis had equally lengthy prediagnosis observation in the health systems (mean and median, 9.1 and 9.1 vs 8.3 and 7.8 years, respectively) but were more likely to have a postdiagnosis hospitalization (32.5% vs 12.5%; P <.001) with greater number of hospital days (358.8 vs 78.5 per 100 person-years; P <.001).

Conclusions: More than one-fifth of patients with newly diagnosed HCV infection during 2014-2016—and more than a quarter of those born between 1945 and 1965—had late diagnosis despite many years of in-system care, an increase of 5 percentage points since 2006-2011, after the interim initiation of age-based screening recommendations. Our data highlight missed opportunities for diagnosis and therapeutic intervention before the onset of severe liver disease, which is associated with high cost and diminished outcomes.

Am J Manag Care. 2019;25(8):369-374
Takeaway Points

Chronic hepatitis C virus (HCV) infection is typically silent until liver disease is advanced; thus, screening and treatment of asymptomatic persons are needed.
  • More than one-fifth of patients with newly diagnosed HCV from 2014 to 2016 in 4 large health systems—and more than a quarter among those born between 1945 and 1965, who are recommended for screening—had diagnosis concurrent with advanced liver disease despite many years of prior care, often with laboratory evidence of hepatic inflammation beginning several years prior to initial HCV diagnosis.
  • These findings suggest a need for earlier screening and treatment, before the onset of severe liver disease, which is associated with high costs and diminished outcomes.
Chronic hepatitis C virus (HCV) infection is typically asymptomatic for many years after primary infection until severe liver disease occurs, and even advanced liver disease may remain undiagnosed for some time; thus, screening and subsequent treatment of asymptomatic persons are needed to prevent poor outcomes. HCV is the most commonly reported bloodborne infection in the United States, with more than 2 million persons estimated to be currently infected.1 The economic and health burdens for patients with severe liver disease are high,2 and treatment of HCV infection at all stages of disease has been demonstrated to be cost-effective.3 All persons with HCV infection are recommended for treatment, with cure rates well over 90% typically achieved with 12 weeks of all-oral therapy.4

Prompt treatment saves lives, but many barriers remain, and this can only be accomplished when infection has been detected and infected patients have been linked to care and treatment.5-7 Updated CDC baby boomer (1945-1965 birth cohort) testing guidelines were released in 2012.8,9 The rationale for this recommendation included the high prevalence of persons with hepatitis C born during these years, the estimated 45% to 85% of persons with HCV infection who do not know they are infected, reports that testing based solely on elevated alanine aminotransferase (ALT) levels is estimated to miss 50% of chronic infections, and the availability of highly effective curative therapy.8,9 If widely implemented, this 1-time test of those born between 1945 and 1965 was predicted to identify 800,000 US infections and to lead to treatment that could avert more than 120,000 HCV-related deaths and save an estimated $1.5 billion to $7 billion in liver disease–related costs.8,9 Although testing has increased since the recommendation, the overall proportion of persons tested in this age group remains quite low,10-13 and recent data are lacking to describe whether increased testing has had an impact on the prevalence of late diagnosis in the United States. Current discussion has included proposals for further expansion of testing.6,7,14

In a previous analysis of data from the Chronic Hepatitis Cohort Study (CHeCS) during 2006-2011, we found that 17% of new HCV diagnoses were among persons who had already progressed to cirrhosis and/or end-stage liver disease (ESLD).15 We sought to examine whether the frequency of these conditions at the time of HCV diagnosis had changed during 2014-2016, after the release of the CDC’s baby boomer birth cohort testing guidelines in 2012.8

METHODS

Criteria for inclusion in and composition of the CHeCS cohort, as well as details of the database created, have been summarized in previous reports.8,16-18 Briefly, the cohort was based on analysis of electronic health records (EHRs) and administrative data of about 2.7 million patients 18 years or older who had a clinical service (ie, outpatient or inpatient, emergency department, or laboratory visit) provided on or after January 1, 2006, at 1 of 4 integrated healthcare systems: Geisinger Health System in Danville, Pennsylvania, which serves approximately 2.6 million Pennsylvania residents in 44 counties; Henry Ford Health System in Detroit, Michigan, which serves more than 1 million southeastern Michigan residents; Kaiser Permanente Northwest in Portland, Oregon, which serves about 500,000 members; and Kaiser Permanente of Honolulu, Hawaii, which serves about 220,000 persons, or approximately one-sixth of Hawaii residents. CHeCS follows the guidelines of HHS regarding the protection of human subjects. The study protocol was approved and is renewed annually by the institutional review board at each participating site. Patients were considered to have confirmed chronic HCV infection based principally on laboratory test results and secondarily on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) criteria. EHR data and administrative data were collected for each cohort patient and supplemented with individual chart review by trained data abstractors, who also reviewed and verified chronic HCV infection from EHR data. Data collected included patient demographics, medical encounters, treatment data, and laboratory, radiology, and biopsy results.


 
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